BEUDAMED
    Product Code: OSN FDA class 2 21 CFR 888.3030

    Software For Diagnosis/Treatment

    Orthopedic

    The Software for Diagnosis/Treatment (product code OSN) is orthopedic software associated with trauma devices, intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions. It provides computational tools to support clinical decision-making for orthopedic trauma cases. As an FDA Class 2 device under regulation 888.3030, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. Notably, this software product is flagged as related to implants in its use context, though the software itself is not implanted. It is not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    4
    Years Active
    12

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    Basic Information

    Product Code
    OSN
    Device Class
    FDA class 2
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K253764 ENOS Software Guided External Fixation System
    K221792 Acute QC Strut and Components
    K180539 Deformity Analysis and Correction Software (DACS) and Instrumentation
    K140550 ORTHOHUB EXTERNAL FIXATOR SOFTWARE

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.